Decision to fund lisdexamfetamine for attention deficit hyperactivity disorder (ADHD)

11 November 2024

Medicines Decision

What we’re doing

We’re pleased to announce that we have made the decision to fund lisdexamfetamine (brand name Vyvanse) supplied by Takeda, for attention deficit hyperactivity disorder (ADHD) from 1 December 2024.

The decision will provide another treatment option for people with ADHD and will ease pressure on the supply of other ADHD medicines.

What does this mean for people?

From 1 December 2024, lisdexamfetamine will be funded when prescribed for people with ADHD who meet certain eligibility criteria. Further detail on the eligibility criteria is outlined in the ‘Details about the decision’ section.

We understand that people respond differently to ADHD treatments and funding lisdexamfetamine will provide an additional once daily treatment option for the management of ADHD. Additionally, there are ongoing supply issues impacting methylphenidate extended release. This decision will make another funded stimulant treatment option available, easing the pressure on the supply of other ADHD medicines.

We anticipate over 6,000 people will receive lisdexamfetamine in the first year of funding, increasing to approximately 13,000 people after five years.

We understand that there are people privately funding lisdexamfetamine. People privately funding this medicine will be able to access publicly funded treatment if they met the eligibility criteria when they first started treatment with lisdexamfetamine. We have changed the eligibility criteria for lisdexamfetamine to make this clear for prescribers.

Who we think will be interested

People with ADHD, their whānau, and caregivers
Paediatricians, psychiatrists, psychologists, medical practitioners, nurse practitioners and other health professionals involved in the care of people with ADHD.
Groups who support and advocate for people with ADHD.
Health New Zealand | Te Whatu Ora
Pharmaceutical suppliers and wholesalers

Any changes to the original proposal?

This decision was subject to a consultation letter released on 12 September 2024. We received feedback from clinicians, advocacy groups, suppliers, consumers, and health sector stakeholders.

We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision-making process. It gives us the opportunity to listen to the voices of the community and acknowledge and respond to feedback.

The feedback received was largely supportive. Some responders requested changes to the proposal, including:

wider access to lisdexamfetamine to allow people to use it with funded dexamfetamine
earlier use of lisdexamfetamine without having to trial other ADHD treatments
increased dosing options for lisdexamfetamine
adding a renewal criteria for lisdexamfetamine for younger age groups.

We have made some changes based on the consultation feedback. We have changed the Special Authority criteria to allow people to use dexamfetamine together with lisdexamfetamine. We understand this will allow greater treatment flexibility. We have also added a criterion for people who are already receiving lisdexamfetamine and would have met the eligibility criteria before starting treatment.

A summary of the feedback we received and our responses

We also received a lot of valuable feedback about how Pharmac can support the implementation of this decision. Based on the feedback, we plan to:

Work with the supplier to ensure availability of appropriate resources and education for consumers and healthcare professionals.
Work with relevant agencies and non-government organisations such as RNZCGP, RANZCP, Health Pathways, BPAC and the New Zealand Formulary to share and provide relevant information on prescribing lisdexamfetamine and training and resources to support prescribers with ADHD management.
Work with Healthify to update information to support people with ADHD management and include information on lisdexamfetamine use.
Work with Health NZ and a clinical reference group led by members of RNZCGP, RANZCP and other professional organisations on a Health Pathway update to support the ongoing management of ADHD treatment.

Details about the decision

From 1 December 2024, lisdexamfetamine (Vyvanse) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical	Formulation	Brand	Pack size	Price and subsidy
Lisdexamfetamine dimesilate	Cap 30 mg	Vyvanse	30	$60.00
Lisdexamfetamine dimesilate	Cap 50 mg	Vyvanse	30	$60.00
Lisdexamfetamine dimesilate	Cap 70 mg	Vyvanse	30	$60.00

A confidential rebate will apply to Vyvanse that reduces the net price to Pharmac. Vyvanse will also have protection from delisting and subsidy reduction until 1 June 2027.

Eligibility criteria

Vyvanse will be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:

Special Authority for subsidy

Initial application only from a paediatrician, psychiatrist, or medical practitioner on the recommendation of a paediatrician or psychiatrist (in writing), or nurse practitioner on the recommendation of a paediatrician or psychiatrist (in writing). Approvals valid without further renewal unless notified for applications meeting the following criteria:

Either:

Patient is currently on treatment with lisdexamfetamine dimesilate and met all remaining criteria prior to commencing treatment; or
All of the following:
1. ADHD (Attention Deficit and Hyperactivity Disorder); and
2. Diagnosed according to DSM-5 or ICD 11 criteria; and
3. Either:
  1. Applicant is a paediatrician or psychiatrist; or
  2. Applicant is a medical practitioner or nurse practitioner and confirms that a paediatrician or psychiatrist has been consulted within the last 2 years and has recommended treatment for the patient in writing; and
4. Any of the following:
  1. Patient is taking a currently subsidised formulation of atomoxetine or methylphenidate hydrochloride (extended-release) and has not received sufficient benefit or has experienced intolerable side effects; or
  2. Patient is taking a currently subsidised formulation of dexamfetamine sulfate (immediate-release) which has not been effective due to significant administration and/or treatment adherence difficulties; or
  3. There is significant concern regarding the risk of diversion or abuse of immediate release dexamfetamine sulfate; or
  4. Patient is taking a currently subsidised formulation of methylphenidate hydrochloride (immediate-release or sustained release) which has not been effective due to significant administration and/or treatment adherence difficulties; or
  5. There is significant concern regarding the risk of diversion or abuse of immediate release methylphenidate hydrochloride; or
  6. Both:
    1. Patient would have been prescribed a subsidised formulation of methylphenidate hydrochloride (extended-release) but has been unable to access due to supply issues with methylphenidate hydrochloride (extended-release); and
    2. Other alternative stimulant presentations (methylphenidate or dexamfetamine) are not appropriate; and
5. Lisdexamfetamine dimesilate is not to be used in combination with another funded methylphenidate presentation.

Similar eligibility criteria will also apply in Part II of Section H of the Pharmaceutical Schedule.

We have decided to remove the renewal criteria for stimulant treatments

Pharmac has made the decision to remove the renewal criteria for stimulant treatments. This is to remove existing barriers to accessing ongoing treatment for those who need it. Therefore, we are also listing Vyvanse without renewal criteria.

Detail on the decision to remove the renewal criteria for stimulant treatments

We have applied a quantity restriction for the 30 mg capsule

A limit of one capsule per day will apply to the 30 mg capsule presentation of lisdexamfetamine. Our clinical advisors have told us 50 mg or 70 mg a day would be clinically appropriate for people requiring higher strengths of lisdexamfetamine. The restriction ensures people who need a higher dose use the higher strength capsules. This reduces the overall cost of lisdexamfetamine and has ensured we can fund it within our fixed budget.

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme	Pharmac Comment
Many responders were supportive of the proposal. Responses highlighted: lisdexamfetamine is a good treatment option in managing ADHD symptoms and improving quality of life. lisdexamfetamine is easier to take than some other funded stimulant treatments, as it is taken once a day. lisdexamfetamine would alleviate supply issues with methylphenidate extended release. funding lisdexamfetamine without a renewal criteria would support access.	We are pleased to progress a proposal that would improve the health outcomes of New Zealanders. The feedback we have received aligns with advice from our expert advisors and our assessment of this proposal.
Supply issues
Some responders indicated there have been supply issues for lisdexamfetamine in the private market. Adequate supply would be important to support access, if publicly funded. We also received feedback that considered lisdexamfetamine should be funded and available earlier to support supply constraints with methylphenidate extended-release brands. A few responders considered that funding an additional generic lisdexamfetamine brand would support supply.	We require suppliers to hold set amounts of stock in New Zealand to minimise risk of a supply issue. We have been working closely with the supplier of lisdexamfetamine to ensure enough stock will be available to supply New Zealand by 1 December 2024, and beyond. The earliest possible list date is 1 December 2024, so there is enough stock available in New Zealand. Vyvanse is currently the only Medsafe approved brand of lisdexamfetamine available. Funding Vyvanse does not stop Pharmac from funding other brands in the future.
Quantity restriction on the 30 mg capsule
Some responders considered that the quantity restriction would limit access for people who need higher doses, if there were supply issues with 50 mg and 70 mg strengths.	Our contract with the supplier requires set amounts of stock to be held in New Zealand to minimise risk of a supply issue. We work closely with all suppliers to minimise the risk and impact of supply issues. This decision does not stop Pharmac from removing this restriction in the future.
Additional dosing options
Some responders considered that a greater range of strength presentations would support supply if other strengths went out of stock and provide greater dose flexibility. We also received feedback that funding the 30 mg capsules for a 60 mg daily dose would provide greater dosing flexibility.	We understand that there has been supply issues with some strengths of lisdexamfetamine for people who have been purchasing lisdexamfetamine privately. We have worked closely with the supplier to make sure enough stock of lisdexamfetamine is available to support funding from 1 December 2024. Our expert advisors have told us that the 30 mg, 50 mg and 70 mg lisdexamfetamine strengths would be clinically appropriate to provide adequate dosing flexibility. This decision does not stop Pharmac from funding more strengths of lisdexamfetamine in the future.
Eligibility criteria amendments
Some responders considered that medical practitioners and nurse practitioners should have the ability to prescribe lisdexamfetamine for ADHD without a written recommendation from a specialist.	Lisdexamfetamine is a controlled drug and has specific legal requirements that set out which prescribers can prescribe treatment for ADHD. More information on these requirements is outlined on the New Zealand Gazette website(external link). We appreciate that there are access constraints to specialists who legally can prescribe or recommend prescribing of lisdexamfetamine. Changes to the regulations about who can prescribe stimulant medicines was not part of this proposal. Should there be changes to the regulations in the future we would revisit this.
Some responders considered it would be beneficial for lisdexamfetamine to be used in combination with dexamfetamine to provide greater treatment flexibility.	We consider the changes requested would allow for greater treatment flexibility and have amended the Special Authority criteria in response to this feedback.
We received feedback that lisdexamfetamine should be available as an earlier treatment option to enable greater treatment choice.	Lisdexamfetamine would be funded as a treatment option after trialling other ADHD treatments, or as an earlier treatment option for people where there are diversion concerns. Lisdexamfetamine would also be funded for people who would otherwise have been prescribed methylphenidate extended release but have been unable to access due to supply issues. Pharmac operates with a fixed budget. We must make difficult choices about what medicine is funded and for whom. The funding criteria are based on the expert advice we have received from our advisors (the Mental Health Specialist Advisory Committee). The eligibility criteria target funded access to those people most likely to benefit. We would welcome a funding application to assess lisdexamfetamine as an earlier treatment option. More information on submitting a funding application can be found on our website. This decision does not stop Pharmac widening access to lisdexamfetamine in the future.
Eligibility criteria clarifications
We received feedback that the eligibility criteria prioritised the use of Concerta (extended-release methylphenidate) over lisdexamfetamine. Some responders considered that people currently privately funding lisdexamfetamine, who have previously met the eligibility criteria should receive fully funded treatment. We received feedback that it is not Pharmac’s role to manage and control diversion issues with stimulant medicines, as this is the responsibility of other agencies. We received feedback that people should be eligible for funded lisdexamfetamine treatment if they find adhering to treatment with shorter acting stimulant medicines distressing, disruptive, or a significant level of difficulty	Lisdexamfetamine is not just funded for people who have tried Concerta (extended-release methylphenidate). It is also funded for people who have trialled other ADHD treatments or where other ADHD treatments are not appropriate. Please refer to details about the decision section above. People privately funding lisdexamfetamine would be able to access publicly funded treatment if they met the eligibility criteria when they first started treatment with lisdexamfetamine. We have changed the eligibility criteria for lisdexamfetamine to make this clear for prescribers. The intent of the criteria is to provide lisdexamfetamine as a first line treatment option for people where there are diversion concerns. This is because our clinical advisors have outlined people with diversion concerns are likely to receive a greater benefit from earlier treatment with lisdexamfetamine. Lisdexamfetamine would be funded for people where treatment with shorter acting stimulant treatments is ineffective due to significant administration or adherence difficulties. We recommend people discuss their treatment options with their prescriber.
Eligibility renewal criteria
Some responders considered that lisdexamfetmaine should have renewal criteria for people with ADHD under the age of 18 years of age and should allow applications from medical practitioners and nurse practitioners with adequate training and support to ensure ongoing review of treatment in this age group.	We acknowledge that treatment review for people with ADHD will remain important. However, we do not consider that funding restrictions are the best way to achieve this. We consider that a review of the appropriateness of ongoing stimulant treatment is best managed by treating clinicians, with support from relevant professional organisations. We will share this feedback with professional organisations and Health NZ that support medical and nurse practitioners in treating people with ADHD. We have a range of planned implementation activities to support these changes. Please also see our planned implementation activities outlined below.
Implementation recommendations
A number of responders provided feedback in relation to information and activities needed to support the implementation of lisdexamfetamine. These included suggested implementation initiatives as follows: Information, training and resources, to support prescribers with ADHD management, treatment review and prescribing lisdexamfetamine. Information and resources in various formats for people using these treatments and their whānau. Information on lifestyle changes and non-medicine options that would work well with lisdexamfetamine treatment. Responders also shared that people with ADHD and their families would benefit from wider availability of counselling services and support networks for ADHD.	We would like to thank the responders for this feedback. We have incorporated this feedback into our implementation activities. Based on the feedback we plan to: Work with the supplier to ensure availability of appropriate resources and education for consumers and healthcare professionals. Work with relevant agencies and non-government organisations such as RNZCGP, RANZCP, Health Pathways, BPAC and the New Zealand Formulary to share and provide relevant information on prescribing lisdexamfetamine and training and resources to support prescribers with ADHD management. Work with Healthify to update information to support people with ADHD management and include information on lisdexamfetamine use. Work with Health NZ and a clinical reference group led by members of RNZCGP, RANZCP and other professional organisations on a Health Pathway update to support the ongoing management of ADHD treatment. We will also share information with Health NZ about the importance of wider availability of counselling services and support networks for people with ADHD.
Other
We received feedback that considered that the $60 list price was unaffordable for people.	Lisdexamfetamine would be fully funded on the Pharmaceutical Schedule by Pharmac from 1 December 2024. This means people who meet the eligibility criteria who are prescribed lisdexamfetamine would have the cost of the medicine funded by Pharmac and only pay a prescription co-payment, if applicable. More information on pharmacy prescription fees \| Health New Zealand website(external link).
We received concerns over whether use of lisdexamfetamine would affect an individual’s ability to gain permanent resident status in New Zealand.	This falls outside of Pharmac’s scope, as we are only responsible for the funding of medicines in New Zealand. We suggest contacting Immigration New Zealand(external link).

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.